The risks for Implantable Collamer Lenses (ICL's) compared to those of refractive surgery are pretty much the same - severely downplayed (but not really any different!). Note the different sources for ICL risks below saying pretty much the same things, and compare to the risks associated with LASIK:
Possible Risks ICL's
Potential Complications of the Visian ICL™ and Other Refractive Procedures
As with any type of surgery, the Visian ICL (Implantable Collamer® Lens) carries
the risk of complications. To help educate prospective patients, the following
information outlines some of the most common risks of the Visian ICL implant
procedure and those of corneal refractive surgery. For detailed information
regarding all possible complications, please ask your doctor.
•Complications Common among Refractive Procedures
•Complications with Corneal Surgery
•Visian ICL Complications
•Complications Common among Refractive Procedures
Refractive procedures, from LASIK surgery to implantable contact lens insertion,
share possible complications.
Overcorrection and Undercorrection
The most common complications with any refractive procedure are overcorrection
and undercorrection. A skilled surgeon will take meticulous measurements before
surgery to determine the right amount of correction; however, these measurements
are not always perfect. No matter the refractive procedure, undercorrection can
be fixed with an additional procedure, which could include a second LASIK or PRK
surgery or the removal and replacement of the Visian ICL. Continued use of
glasses or contact lenses is also a possibility.
Because all of these procedures involve some form of manipulation (no matter how
slight), there is a risk of an infection. Although it is not a common
complication, it is important to realize that an eye infection may range from
delaying the healing of the eye to serious damage, including possible loss of
Halos and Night Glare
The most common side effects of corneal refractive surgery are halos and glare
around lights at night. These problems range in severity from being barely
noticeable to severely limiting a person's visual acuity. In many cases, severe
halos and night glare can be reduced with a second surgery, but it is often
difficult to eliminate these effects completely.
Loss of Visual Acuity
Although extremely rare, there is the possibility that a refractive procedure
can cause damage to the eye including loss of visual acuity.
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Complications with Corneal Surgery
Corneal surgery, including LASIK and PRK, requires that a small portion of the
cornea be removed to change the shape and focusing ability of the eye.
There is increasing concern in the ophthalmic community regarding dry eye and
the decision to perform LASIK. Dry eye is a common disease that often causes
patients to seek LASIK because of difficulty wearing contact lenses. According
to Toda, et al, in the August 2002 Archives of Ophthalmology, “more than 75
percent of the patients undergoing LASIK have preoperative dry eye.” 1
Additionally, some 59.4 percent of those patients who do not have dry eye
preoperatively will end up with it postoperatively2. There is also general
consensus that worsening of preexisting dry eye occurs after LASIK.
Problems with the Corneal Flap
Some of the complications of LASIK eye surgery stem from the corneal flap. It
may be too thin or too thick or sometimes irregular. Diffuse lamellar keratitis,
or DLK, describes another flap-related problem that develops when epithelial
cells migrate beneath the flap. These complications are not associated with the
Visian ICL surgery as the cornea remains untouched.
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Visian ICL Complications
Some complications associated with the Visian ICL differ from those associated
with LASIK or PRK. For a complete discussion of all complications, please ask
Damage to the Crystalline Lens
Since the Visian ICL is placed inside the eye, potential risk touching the eye's
natural lens may result. Damage to the natural lens may cause an opacity of the
lens, in the most serious case, requiring removal and replacement of the natural
lens with a synthetic lens. These opacities, requiring surgical intervention,
occurred in less than 1 percent of the Visian ICL patients3.
Complications of Iridotomy
One to two weeks prior to the implantation of the Visian ICL, the surgeon will
perform a procedure called an iridotomy. Using a YAG-laser, the doctor will make
one or two small openings near the edge of your iris. Complications from the
iridotomy are rare, but could possibly include natural lens or corneal damage,
inflammation, temporary increase in intraocular pressure, bleeding, and scar
Increase in Eye Pressure
In some cases, there may be an increase in eye pressure. If this occurs, a
surgeon may quickly remedy the problem with additional medications or surgical
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Advantages over Laser Refractive Surgery
Many patients who compare the side effects of laser refractive eye surgery and
implantable contact lens complications decide that the benefits of the Visian
ICL far outweigh the rare risks associated with it. Because implantation of the
lens does not physically change any part of the cornea or other part of the eye,
side effects such as halos and glare are almost nonexistent. Also, should any
problems with the lens arise, the Visian ICL is completely removable. Learn more
about the advantages of our phakic IOL.
If you are interested in undergoing the Visian ICL procedure, find a qualified
Visian ICL Surgeon in your area who can discuss the risks and benefits as they
pertain to your individual medical history and goals. To learn more about the
clinical trials that assessed the safety of the Visian ICL, Contact STAAR®
Surgical Company today.
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1. Toda I, Asano-Kato N, Hori-Komai Y, Tsubota K. Laser-Assisted In Situ
Keratomileusis for Patients With Dry Eye. Archives of Ophthalmology.
2. Yu E, Leung A, Rao S, Lam DSC. Effect of laser in situ keratomileusis on tear
stability. Ophthalmology, 2000; 107:2131-2135
3. ICL in Treatment of Myopia (ITM) Study Group. United States Food and Drug
Administration clinical trial of the Implantable Collamer Lens (ICL) for
moderate to high myopia. Ophthalmology. 2004;111:1683-1692
- Increased risk of retinal detachment: Nearsighted people usually
have longer eyes that can result in fragile retinas, which are more prone to
retinal holes or tears. Any surgery within the eye carries a risk of retinal
detachment, and this risk increases as the amount of nearsightedness
increases. The risk of retinal detachment is low for farsighted patients.
- Risks associated with surgery within the eye: Since an ICL is an
intraocular procedure, the risks associated with cataract surgery are also
relevant to ICL surgery. The following complications are extremely uncommon,
but they can occur: hemorrhage within the eye; infection within the eye;
induced astigmatism; swelling around the eye and increased dryness of the eye.
Other complications associated with ICL procedures are reflections or slight
distortions from the lens implant; an increase in the number, shape or size of
floaters; potential for early cataract development; loss of corneal clarity;
wound leak; pigment dispersion glaucoma and uveitis (i.e., inflammation). It
is worth noting, some complications of intraocular surgery are associated with
local anesthesia and are not a concern for people who have topical anesthesia.
Typically, surgeons perform ICL surgery using topical anesthesia instead of
local anesthesia, which uses needles.
- Risks associated with removal of ICL: Potential complications of
surgery to remove the ICL can include premature cataract formation; corneal
damage; inflammation; infection leading to loss of the eye; damage to the iris
as well as other
Implantable Contact Lens Risks
When considering refractive surgery of any kind, you should be aware of each
procedure's possible complications. Potential ICL risks include:
Overcorrection – This complication occurs if the prescriptive power
of the implanted ICL is too strong. In most cases it can be corrected with
corrective eyewear or with an ICL replacement.
Undercorrection – The opposite of overcorrection, undercorrection is
the result of an implantable contact lens with too weak of a prescription.
Correction methods are similar to those of overcorrection.
Infection – During most surgeries, there is a potential of an
infection. Severe infection during ICL implantation is rare.
Increased intraocular pressure – Pressure may build in the eye after
an ICL procedure. The sooner a surgeon is alerted to this complication, the
greater the chance of avoiding serious damage.
Repositioning or removal of lens –ICLs have the potential, however
slight, of needing to be repositioned. The frequency of this complication may
vary by implantable contact lens models.
Damage to crystalline lens – Because implantable contact lenses are
implanted into the eye, there is a potential that the eye's natural lens may be
damaged during the procedure. If the damage is severe, the crystalline lens may
need to be replaced with an intraocular lens.
Cataract development – Over 50 percent of the population will
cataracts by the age of 65, however, it is believed that the use of some
implantable contact lenses may cause cataracts at an earlier age.
Halos, glare, and double vision – Updated ICL models greatly
diminish the risks of halos, glare, and double vision.
Retinal detachment – Less than 1 percent of patients in the clinical
studies for both the
Verisyse™ phakic IOL and the
ICL™ were affected by retinal detachment. It should be noted, however, that
the occurrence of retinal detachment increased as the degree of myopia
Vision loss – Extremely rare, there is a possibility of vision loss
from this refractive procedure. Typically the loss of visual acuity is due to
bleeding, severe inflammation, or an untreated infection.
Understanding ICL Risks
It is important to note that several of the ICL risks listed above are
potential complications of all refractive procedures, including:
- Halos, glare, and double vision
- Vision loss
Risks of Lens Implantation
As with any surgical procedure, complications are rare but can occur after
implantation of phakic IOLs.
Possible complications include increased chance of
detachment, loss of cells in the thin layer inside the cornea (endothelium),
inflammation, infection and
The FDA warns of other potential complications such as sometimes severe
vision loss. Problems also can develop with night driving and may include halos,
increased eye pressure (intraocular
pressure) that can damage the eye's
optic nerve and inadequate lens power that may not properly correct vision.
After surgery, your doctor will continue monitoring your endothelial cell
counts, an indicator of how healthy your corneas are and how well they heal
At the 2006 Joint Meeting of the American Academy of Ophthalmology (AAO) and
Asia Pacific Academy of Ophthalmology, a researcher said that — when comparing
studies of the Verisyse and Visian ICL — the following complication rates were
Visian ICL and Verisyse Complication Rates
|Endothelial cell loss
|Notes: Buratto L. "Phakic IOLs: which
approaches are likely to be effective and safe?" Program and abstracts of
the 2006 Joint Meeting of the American Academy of Ophthalmology and Asia
Pacific Academy of Ophthalmology; November 11-14, 2006; Las Vegas, Nevada.
Refractive Surgery Subspecialty Day.
In Visian ICL studies performed after approval, patients had lower rates of
glaucoma and endothelial cell loss and higher rates of retinal detachment and
cataracts, compared with clinical trials.
All complication rates were lower for the Verisyse in studies conducted after
initial FDA approval.
Because phakic IOLs are a relatively new technology, long-term effects and
potential risks of lens implantation are unknown.
WHAT ARE THE RISKS?
any refractive surgical procedure, there are certain risks and complications
associated with the INTACS procedure. These risks include infection, shallow
placement of the INTACS inserts into the tunnel, deposits in the tunnel where
the INTACS inserts are placed, haze in the incision area, visual symptoms
(including discomfort, burning, itching, tearing, double vision, increased
sensitivity to light, glare and halos around lights, fluctuating vision, and
reduced vision at night), shallow segment placement, a non-infectious healing
response and developing blood vessels in the cornea. It is important to discuss
these risks with your doctor before you make the decision to have your surgery.
If the results of your INTACS procedure are not satisfactory, you may need to
INTACS inserts removed or replaced. If your INTACS inserts are removed, you may
need to have a corneal transplant procedure. The long-term safety risks of using
INTACS inserts in the keratoconus population are unknown. There may be other
risks associated with INTACS inserts that cannot be foreseen at this time.
Other Possible Complications:
possible risks include corneal ulcer formation; endothelial cell loss (loss of
cell density in the inner layer of the cornea, possibly resulting in corneal
swelling); ptosis (droopy eyelid); corneal swelling; retinal detachment and
hemorrhaging. Complications could also develop that require further corrective
procedures including either a partial (lamellar) or full-thickness corneal
transplant using donor cornea. These complications include loss of corneal disc;
damage to the corneal disc; disc decentration; progressive corneal thinning (ectasia).
Sutures may also be required, which could induce astigmatism. It is also
possible that the instrument that creates the tunnel goes too deep and passes
through the back of the cornea and enters the anterior chamber of the eye which
may require suturing. This would preclude inserting the INTACS inserts until the
eye healed. It is also possible the instrument could create a tunnel that was
too shallow and exit the front of the cornea, which may preclude inserting the
INTACS inserts until the eye healed. There are also potential complications due
to anesthesia and medications that may involve other parts of your body. Since
it is impossible to state all potential risks of any surgery or procedure, this
Informed Consent form does not provide a comprehensive listing of every
conceivable problem that you may encounter.
should be aware that having this surgery may affect future employment
opportunities with certain military or law enforcement agencies.
INTACS procedure is a relatively new technique. You should be aware that other
complications might occur that have not yet been reported. Longer-term results
may reveal additional risks and complications. After the procedure, you should
continue to have routine check-ups to assess the condition of your eyes. INTACS
inserts may not prevent the
need for corneal transplant at some point in the future. It is unknown how
INTACS inserts will affect the course of your keratoconus. This is why it is
important we continue long-term follow-up on you, either in our clinic or
through other health care providers, if you live far away.
Risks of Not Undergoing the INTACS Procedure:
risks of not having the surgery are limited to those associated with your
current visual condition. These include but are not limited to the dangers that
may be associated with losing your glasses or contact lenses, the risks of
corneal distortion and/or infection from wearing contact lenses, and the risks
of trauma to the eye caused by breakage of glasses or contact lenses in the eye.
Although no procedure is risk free, the risks of serious damage to the eye from
ICR surgery are minimal and include the possibility of infection introduced at
the time of surgery, surface cells of the eye (epithelium) growing into the
tracks where the rings have been implanted requiring removal of the ring, and
the remote possibility of permanent damage to the cornea or the inside of the
eye. Any surgery on the eye can result in a permanent decrease or loss of
vision. Fortunately, severe complications are exceedingly low. Side effects of
the ICR include glare, halos, difficulty with vision at night, and fluctuation
of vision throughout the day.
Even if a complication does not occur, as with all surgical refractive
procedures, patients may not be 100% satisfied with the result and/or may
require the use of glasses to "fine tune" the vision for distance tasks such as
driving by day or night. Additionally, if monovision is not performed, patients
over 40 having both eyes corrected for distance will require reading glasses
just as they would if they had not had surgery but continued to wear contact
If for any reason a patient is not satisfied with the vision following
implantation of the ring segments, they can be removed. In almost all cases the
eye is returned to (or very close to) its original refraction (amount of
nearsightedness). In some cases following removal, the amount of nearsightedness
and/or astigmatism is not identical to pre-operative levels and a new spectacle
(or contact lens) prescription is required. In some cases following removal, the
amount of nearsightedness and/or astigmatism is slightly more or slightly less
than pre-operative levels. In some cases following removal of the segments there
will be a small amount of astigmatism (curvature of the cornea) actually induced
by the surgery where none had existed before the surgery.